ICIPRESIST19: Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519)

Sponsor
Russian Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04025424
Collaborator
(none)
350
1
53.6
6.5

Study Details

Study Description

Brief Summary

This is a multicenter, non-interventional, retrospective study (with two prospective cohorts), including previously treated patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin disease at any stages.

The duration of the follow-up will be 12-60 months. Data from medical records will be retrospectively collected at different points in time. The first data extraction will consist of collecting data from the initial level (before treatment with immune checkpoints inhibitors (anti-PD1 / PDl1) before the end of the recruitment period for this study (up to 3 years of follow-up). Two additional annual data collections are planned for display additional follow-up and data for patients who will survive.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Genetic tests of the available tumor and plasma samples

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Observational Study of Genetic Predictors of Efficiency and Safety of Immune Checkpoints Inhibitors in Patients With Different Malignancies (ICIPRESIST-0519)
Actual Study Start Date :
Jun 15, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Skin melanoma, retrospective

1) Clinically and morphologically verified diagnosis of skin melanoma or melanoma metastases without an identified primary lesion; 2) The availability of basic clinical information about the patient and the course of his illness;

Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Hodgkin disease, retrospective

1) Clinically and morphologically verified diagnosis of Hodgkin disease (any histological variant); 2) The availability of basic clinical information about the patient and the course of his illness;

Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Uveal melanoma, retrospective

1) Clinically and morphologically verified diagnosis of uveal melanoma (any histological variant); 2) The availability of basic clinical information about the patient and the course of his il

Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Skin melanoma, proscpective

1) Clinically and morphologically verified diagnosis of metastatic melanoma; 2) The availability of basic clinical information about the patient and the course of his illness;

Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Lung cancer, procpective

1) Clinically and morphologically verified diagnosis of metastatic or inoperable squamous cell lung cancer; 2) The availability of basic clinical information about the patient and the course of his illness; 3) The presence of indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;

Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Outcome Measures

Primary Outcome Measures

  1. overall survival (OS) of patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and lymphoma granulomatosis [dec 2021]

    Overall survival (OS) will be calculated and presented in graphical form using the method of the product of Kaplan-Meier limits. The report will include a median of C with corresponding bilateral values of 95% CI. The proportion of patients who survive at certain points in time (1, 2, and 3 years), as well as the corresponding bilateral values of 95% CI, will be evaluated and reported.

  2. incidence and severity of all adverse events (AEs) in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and lymphoma. [dec 2021]

Other Outcome Measures

  1. progression-free survival (PFS) in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and Hodgkin disease [dec 2021]

  2. response rate in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and Hodgkin disease [dec 2021]

  3. Development of predictive molecular testing tools [dec 2021]

    The predictive power parameters of the predictive tools being developed will be generalized using descriptive statistics methods. The significance of the results of the qualitative tests will be assessed using Fisher's two-sided exact test. The optimal threshold values for quantitative tests will be evaluated using the ROC curve method, and for the mutational load, the four squares method of Abeshouse, 2017 will also be calculated. using the proportional Cox test.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
To participate in this study, the patient must meet the following criteria:
  • At least 2 injections (or 10 weeks) of ICI (PD1, PDl1 blockers, including but not limited to such drugs as nivolumab, pembrolizumab, prolglimab, atezolizumab, avelumab, durvalumab, spratalizumab)

  • Deceased patients meet the criteria; signing the informed consent of the legal representative of the deceased patient is not required

Specific inclusion criteria for individual cohorts:
  • Cohort 1 (retrospective cohort of skin melanoma patients)

    1. Clinically and morphologically verified diagnosis of skin melanoma or melanoma metastases without an identified primary focus;
    1. The availability of basic clinical information about the patient and the course of his illness;
    1. Therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy (at least 2 injections);
    1. Evaluation of the effect of immunotherapy
    1. Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies, obtained no earlier than 24 months. before initiating therapy with a PD-1 or PD-L1 inhibitor;
    1. Patient-signed informed consent in case the patient is alive
  • Cohort 2 (Hodjkin disease - retrospective)

    1. Clinically and morphologically verified diagnosis of Hodgkin disease (any histological variant);
    1. The availability of basic clinical information about the patient and the course of his illness;
    1. Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies;
    1. Patient signed informed consent.
  • Cohort 3 (Uveal melanoma - retro)

    1. Clinically and morphologically verified diagnosis of uveal melanoma (any histological variant);
    1. The availability of basic clinical information about the patient and the course of his illness;
    1. Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies;
    1. Patient signed informed consent.
  • Cohort 4 (melanoma of the skin - prospective)

    1. Clinically and morphologically verified diagnosis of metastatic melanoma;
    1. The availability of basic clinical information about the patient and the course of his illness;
    1. Indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;
    1. The possibility of including the patient in the present study before the first course of immunotherapy;
    1. Availability of tumor material (paraffin blocks and histological glass preparations) for morphological, immunohistochemical and molecular genetic studies obtained no earlier than 2 years before the planned start of immunotherapy with a standard PD-1 inhibitor;
    1. Separate patient consent to a repeated biopsy of the tumor focus before the planned start of immunotherapy with a PD-1 or PD-L1 inhibitor, if the existing tumor material was obtained earlier than 2 years before the planned start of immunotherapy
    1. Availability of samples of biological fluids collected before the start of immunotherapy and after the first course of immunotherapy for molecular genetic studies of circulating tumor DNA;
    1. Evaluation of the effect of therapy in the framework of local practice in accordance with the criteria of RECIST 1.1
    1. Signed by the patient informed consent to participate in the study.
  • Cohort 5 (squamous cell lung cancer - prospective)

    1. Clinically and morphologically verified diagnosis of metastatic or inoperable squamous cell lung cancer;
    1. The availability of basic clinical information about the patient and the course of his illness;
    1. The presence of indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;
    1. The possibility of including the patient in the present study before the first course of immunotherapy;
    1. Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic research, obtained no earlier than 2 years before the planned start of immunotherapy with a standard PD-1 inhibitor;
    1. Separate patient consent to a repeated biopsy of the tumor focus before the planned start of immunotherapy with a PD-1 or PD-L1 inhibitor, if the existing tumor material was obtained earlier than 2 years before the planned start of immunotherapy
    1. Availability of samples of biological fluids collected before the start of immunotherapy and after the first course of immunotherapy for molecular genetic studies of circulating tumor DNA;
    1. Evaluation of the effect of therapy in the framework of local practice in accordance with the criteria of RECIST 1.1
    1. Signed by the patient informed consent to participate in the study.
Exclusion Criteria:
  • Cohort 1 (retrospective cohort of skin melanoma patients)

    1. It is not allowed to conduct other immunotherapy (anti-CTLA4, vaccines, etc.) to patients before the course of therapy with a PD-1 or PD-L1 inhibitor in a standard dosage in monotherapy
  • Cohort 2 (Hodgkin disease - retrospective)

  • no special exclusion criteria

  • Cohort 3 (Uveal melanoma - retro)

  • No special exclusion criteria.

  • Cohort 4 (melanoma of the skin - prospective)

    1. It is not allowed to include patients who have previously undergone other immunotherapy (anti-CTLA4, vaccines, etc.) before the course of therapy with the PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy
    1. It is not allowed to include patients who are scheduled for combination immunotherapy (anti-PD1 + anti-CTLA4, vaccines, etc.) after inclusion in this study
  • Cohort 5 (squamous cell lung cancer - prospective)

    1. It is not allowed to include patients who have previously undergone other immunotherapy (anti-CTLA4, vaccines, etc.) before the course of therapy with the PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy
    1. It is not allowed to include patients who are scheduled for combination immunotherapy (anti-PD1 + anti-CTLA4, vaccines, etc.) after inclusion in this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 N.N. Blokhin Russian Cancer Research Center Moscow' Москва Russian Federation 115478

Sponsors and Collaborators

  • Russian Academy of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Igor Samoylenko, MD, PhD, Principal Investigator, Senior Researcher, Tumor biotherpay Department, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT04025424
Other Study ID Numbers:
  • ICIPRESIST-052019
First Posted:
Jul 18, 2019
Last Update Posted:
Dec 28, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2021